Cevostamab in relapsed or refractory multiple myeloma
Official title: An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Run by Genentech, Inc. · NCT04910568 · Data updated 2026-11-12
This early-stage trial tests cevostamab alone or with standard therapies to see if it is safe and how it behaves in people with relapsed or refractory multiple myeloma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 186 (estimated) |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Drugs / interventions | cevostamab, tocilizumab, daratumumab, CAR T, chimeric antigen receptor, radiation, prednisone |
| Locations | 34 sites (Duarte, California and 33 other locations) |
| Status | Recruiting |
| Started | July 26, 2021 |
| Main results expected | December 21, 2028 |
| Study ends | December 21, 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT04910568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with relapsed or refractory multiple myeloma who have measurable disease and adequate organ function, and who have had prior anti-mye therapy with appropriate recovery from prior treatments.
✕Probably not a fit
Patients with rapidly progressing disease or those not deriving benefit from the study treatments may not experience improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab as a single agent and in combination with pomalidomide-dexamethasone or daratumumab-dexamethasone in patients with relapsed or refractory multiple myeloma. Participants will receive intravenous infusions and be closely monitored for adverse events and drug behavior in the body. The trial aims to establish a safe dose range and explore preliminary anti-myeloma activity of the regimens. Eligibility requires measurable disease, good performance status, and prior therapy considerations; women and men have contraception or abstinence requirements during and after treatment. Locations include three U.S. cancer centers with Genentech and Roche as sponsors.
Why it matters
Potential benefit: If successful, cevostamab-based regimens could offer a new treatment option for patients with relapsed or refractory multiple myeloma.
How similar studies have gone: Previous studies with similar monoclonal approaches in myeloma have shown signals of activity and acceptable safety in early phases, supporting further exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Agreement to provide bone marrow biopsy and aspirate samples * Resolution of adverse events from prior anti-cancer therapy to Grade \<=1 * Measurable disease * For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered * For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria * Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria * For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) * For Cohort B2S, B1E, B3E: Participants with R/R MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD * For Cohort B4E: Participants with R/R MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy * Agreement to comply with all requirements of the pomalidomide pregnancy prevention program * For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered * For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria * For Cohort C1S: Patients with R/R MM who have received at least two prior lines of treatment including a PI and an IMiD * For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy * For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered * For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period Exclusion Criteria: * Prior treatment with cevostamab or another agent targeting FcRH5 * Inability to comply with protocol-mandated hospitalization and activities restrictions * Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable). * Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy * Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment * Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment * Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment * Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment * Autologous SCT within 100 days prior to first study treatment * Prior allogeneic stem cell transplant(ation) (SCT) * Circulating plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells * Prior solid organ transplantation * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * Known history of amyloidosis * Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare * History of other malignancy within 2 years prior to screening * Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM * Significant cardiovascular disease * Symptomatic active pulmonary disease or requiring supplemental oxygen * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection * Known or suspected chronic active Epstein-Barr virus (EBV) infection * Recent major surgery within 4 weeks prior to first study treatment * Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection * Acute or chronic hepatitis C virus (HCV) infection * Known history of Grade \>= 3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies * Known history of hemophagocytic lymphohistiocytosis (HLH) or immune effector cell associated hemophagocytic lymphohistiocytosis like syndrome (IEC HS) * Active symptomatic coronavirus disease 2019 (COVID-19) infection at study enrollment or requiring treatment with intravenous (IV) antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment * Positive and quantifiable EBV polymerase chain reaction (PCR) or Cytomegalovirus (CMV) PCR prior to first study treatment * Known history of HIV seropositivity * Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment \<=10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment * History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment Additional Arm B-Specific Exclusion Criteria * Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, (including treatment interruptions) or within 4 weeks after the last dose of pomalidomide * Significant cardiovascular disease (such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 12 months, uncontrolled arrhythmias, or unstable angina) * History of erythema multiforme, Grade \>=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide * Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis * GI disease that might significantly alter absorption of oral drugs Additional Arm C-Specific Exclusion Criteria * Pregnant or breastfeeding, or intending to become pregnant during the study or within 102 days after the last dose of daratumumab * Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of daratumumab formulations * Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal * Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification
Where it's running
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Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado, United States Recruiting -
The Alfred Hospital
Melbourne, Victoria, Australia Recruiting -
Sourasky Medical Centre
Tel Aviv, Israel Recruiting -
University College London Hospitals NHS Foundation Trust
London, United Kingdom Recruiting -
City of Hope
Duarte, California, United States Active not recruiting -
City of Hope - Lennar Foundation Cancer Center
Irvine, California, United States Active not recruiting
Show 28 more locations
-
Winship Cancer Institute
Atlanta, Georgia, United States Withdrawn -
Karmanos Cancer Institute.
Detroit, Michigan, United States Completed -
Washington University School of Medicine
St Louis, Missouri, United States Active not recruiting -
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia Active not recruiting -
Cross Cancer Institute
Edmonton, Alberta, Canada Active not recruiting -
Hamilton Health Sciences
Hamilton, Ontario, Canada Active not recruiting -
University Health Network
Toronto, Ontario, Canada Active not recruiting -
Fakultni Nemocnice Ostrava
Ostrava, Czechia Active not recruiting -
I Interni klinika
Prague, Czechia Withdrawn -
Rigshospitalet
København Ø, Denmark Active not recruiting -
Hôpital Saint-Louis
Paris, France Withdrawn -
CHU de Poitiers - La Miletrie
Poitiers, France Active not recruiting -
CHU Pontchaillou
Rennes, France Withdrawn -
Rambam Medical Center
Haifa, Israel Active not recruiting -
Asst Papa Giovanni Xxiii
Bergamo, Lombardy, Italy Active not recruiting -
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy Completed -
Nagoya City University Hospital
Aichi, Japan Withdrawn -
National Hospital Organization Okayama Medical Center
Okayama, Japan Withdrawn -
The Cancer Institute Hospital of JFCR
Tokyo, Japan Withdrawn -
Yamagata University Hospital
Yamagata, Japan Active not recruiting -
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland Withdrawn -
Pratia Onkologia Katowice
Katowice, Poland Active not recruiting -
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland Withdrawn -
Seoul National University Hospital
Seoul, South Korea Active not recruiting -
Samsung Medical Center
Seoul, South Korea Active not recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Active not recruiting -
Hospital General Universitario Gregorio Marañon
Madrid, Spain Active not recruiting -
Royal Marsden Hospital
Sutton, United Kingdom Active not recruiting
Study contacts
- Study coordinator: Reference Study ID Number: GO42552 https://forpatients.roche.com/No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma
This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.
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Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis
This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.
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Cevostamab with pomalidomide and dexamethasone vs standard care in previously treated multiple myeloma
This study tests whether adding cevostamab to pomalidomide and dexamethasone helps people with multiple myeloma who have already had some prior treatments and exposure to anti-CD38 therapy and lenalidomide.
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Maintaining myeloma with less frequent daratumumab plus lenalidomide
This phase 2 study tests a reduced-dosing schedule of daratumumab with lenalidomide to maintain remission in adults with multiple myeloma after stem cell transplant.
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GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
This trial tests whether GR1803 injection works better than daratumumab combined with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma who have had one to three prior treatments.
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Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma
This study tests whether belantamab mafodotin plus standard multiple myeloma drugs works better than daratumumab plus the same drugs for people newly diagnosed and ineligible for transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.